Bariatric Device and Method for Weight Loss

ABSTRACT

A bariatric device for use in inducing weight loss, comprising a cardiac element, a pyloric element, and a connecting element between the two other elements, wherein the connecting element provides structure between the cardiac and pyloric elements, keeping them largely in place and at least intermittently touching and applying pressure to the stomach&#39;s cardiac, adjacent fundic and pyloric regions, respectively, which produces a satiety signal to the user, giving the recipient a feeling of fullness and reducing his or her hunger feelings. In an alternative embodiment, the pyloric and connecting elements may be replaced with a positioning element, which keeps the cardiac element in its relative position by pushing against various structures in the stomach. In any of the embodiments, the bariatric device may be made from multiple sizes or adjustable, either manually, automatically or remotely, to optimally size and/or position the device to produce the desired satiety signals and weight loss.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Ser. No. 13/503,273, filedApr. 20, 2012, and now issued as U.S. Pat. No. 9,532,892, which claimsbenefit under 35 USC §371 to PCT/US10/41774, filed Jul. 13, 2010, whichclaims the benefit of U.S. Provisional Application No. 61/253,816, filedOct. 21, 2009, U.S. Provisional Application No. 61/262,040, filed Nov.17, 2009, U.S. Provisional Application No. 61/262,045, filed Nov. 17,2009, and U.S. Provisional Application No. 61/264,651, filed Nov. 25,2009.

TECHNICAL FIELD

This invention relates to a bariatric device for weight loss, andancillary items such as sizing, deployment, and removal apparatus.

BACKGROUND

Obesity has been steadily increasing worldwide and poses serious healthrisks, which if untreated, can become life threatening. There arevarious methods for reducing weight such as diet, exercise, andmedications but often the weight loss is not sustained. Significantadvances have been made in the surgical treatment of obesity. Surgicalprocedures such as the gastric bypass and gastric banding have producedsubstantial and lasting weight loss for obese patients. These proceduresand products have been shown to significantly reduce health risks overtime, and are currently the gold standard for bariatric treatment.

Although surgical intervention has been shown to be successful atmanaging weight loss, both procedures are invasive and carry the risksof surgery. Gastric bypass is a highly invasive procedure which createsa small pouch by segmenting and/or removing a large portion of thestomach and rerouting the intestines permanently. Gastric bypass and itsvariations have known complications. Gastric banding is an invasiveprocedure which creates a small pouch in the upper stomach by wrapping aband around the stomach to segment it from the lower stomach. Althoughthe procedure is reversible, it also carries known complications.

Less invasive or non-invasive devices that are removable and capable ofsignificant weight loss are desirable.

SUMMARY

The bariatric device described herein induces weight loss by engagingthe upper and lower regions of the stomach. One embodiment of thebariatric device disclosed herein is based on applying force or pressureon or around the cardiac opening or gastroesophogeal (GE) junction andupper stomach. It may also include pressure in the lower esophagus. Thedevice can be straightened or compressed to allow for introduction downthe esophagus and then change into the desired shape inside the stomach.This device may not require any sutures or fixation and would orientinside the stomach based on the device's geometry. The device may beconstructed of 2 main elements:

-   -   1) A cardiac element that contacts or intermittently contacts        the upper stomach around the GE junction and may also contact        the lower esophagus.    -   2) A positioning element that maintains the position of the        first element in the stomach.

One of the purposes of the cardiac element which contacts the upperstomach or cardia is to at least intermittently apply direct force orpressure to this region of the stomach. Applying force or pressure tothis region of the stomach replicates the forces and pressures that aregenerated during eating and swallowing. It also engages or stimulatesthe stretch receptors that are present in this region of the stomach.During eating, as the stomach fills, peristalsis starts and generateshigher pressures in the stomach for digestion, which activates thestretch receptors to induce a satiety response, and may also trigger aneurohormonal response to cause satiety or weight loss. The cardiacelement replicates this type of pressure on the stretch receptors. Thecardiac element could take the form of many different shapes such as aring, a cone, a frusto-cone, a sphere, an oval, an ovoid, a pyramid, anopen or closed polyhedron, a square, a spiral, a kidney shape, multipleprotuberances, multiple spheres or multiples of any shape or otherstructure. It could also be an inflatable balloon or contain aninflatable balloon. This balloon could be spherical, or it could be atorus or a sphere with channels on the side to allow food to pass, or itcould be a cone or other. For the purpose of the claims of this patent,the “upper stomach” includes the cardiac region (a band of tissue in thestomach that surrounds the gastroesophogeal (GE) junction), and thefundus adjacent to the cardiac region, and may be either of these twoareas, or both.

Some of the purposes of the positioning element are to provide structurefor the device to maintain its relative placement location, providesupport for the cardiac element to apply constant, intermittent, orindirect pressure against the upper stomach, and to prevent the devicefrom migrating into the duodenum or small intestine. The positioningelement may also be constructed in such a manner as to impart anoutwardly biasing force between the stomach and the cardiac element, sothat the cardiac element can maintain at least intermittent pressureagainst the upper stomach, including the cardiac region and the adjacentportion of the fundus. This positioning element would be preferentiallyin the stomach above the pyloric valve. The positioning element couldalso take the form of a wire, a taper, a tube, a ribbon, a spiral of asingle diameter, a spiral of varying diameter, an I-beam, or othersuitable shapes. Similarly, the positioning element could comprisemultiple members to improve its structural integrity. The positioningelement could be generally curved to match the greater curve or lessercurve of the stomach, or both, or could be straight, or a combination ofany of the above. Similar to the cardiac element, the positioningelement could also take several different shapes, such as a ring, acone, a sphere, an oval, a kidney shape, a pyramid, a square, a spiral,multiple protuberances, multiple spheres or multiples of any shape orother. It could also be an inflatable balloon or contain an inflatableballoon. This balloon could be spherical, or it could be a torus or asphere with channels on the side to allow food to pass, or it could be acone, a portion of a cone or other shape. The positioning element couldbe a combination of a curved wire and a balloon or any combination ofthe above mentioned forms. The form and structure of the cardiac andpositioning elements may vary to adapt appropriately for their purpose.The positioning element may activate stretch receptors or aneurohormonal response to induce satiety or another mechanism of weightloss by contacting or stretching certain portions of the stomach, toinduce satiety, delayed gastric emptying or another mechanism of weightloss.

After eating or drinking, the stomach goes through peristalsis to grindup the consumed food, and to propel the contents through the pyloricvalve into the duodenum. Peristalsis causes the stomach to constantlychange shape, length and diameter. Due to this constant motion, it isanticipated that this embodiment will move within the stomach. Thepositioning element may slide back and forth along the greater curve,the lesser curve or along the side walls of the stomach. The positioningelement may intermittently engage the lower stomach or pyloric valve,but be of a large enough size to prevent passage through the valve intothe duodenum. The positioning element may include elements that arecompressible to allow them to pass from a larger portion of the stomachinto a smaller portion of the stomach such as from the body into thepyloric region, while exerting pressure or intermittent pressure on thecardiac element. Alternatively, the positioning element could havelimited compressibility to maintain its position within the stomach.

In another embodiment of the bariatric device disclosed herein, thedevice may be constructed of three main elements:

1) A cardiac element that engages the upper stomach around the GEjunction including the cardiac region and adjacent fundus and mayinclude the lower esophagus.

2) A pyloric element that engages the pyloric region which includes thepyloric antrum or lower stomach.

3) A connecting element that connects the cardiac and pyloric elements.

One of the purposes of the cardiac element which contacts the upperstomach or cardiac region would be to apply at least intermittentpressure or force to engage a satiety response and/or cause aneurohormonal response to cause a reduction in weight. This elementcould take the form of many different shapes such as a ring, a cone,frusto-cone, a sphere, an oval, a pyramid, a square, a spiral, multipleprotuberances, multiple spheres or multiples of any shape or othersuitable shapes. It could also be an inflatable balloon or contain aninflatable balloon. This balloon could be spherical, or it could be atorus or a sphere with channels on the side to allow food to pass, or itcould be a cone, a portion of a cone or other shapes. The cardiacelement may be in constant or intermittent contact with the upperstomach based on the device moving in the stomach during peristalsis.

Some of the purposes of the pyloric element are to engage the pyloricregion or lower stomach, and to act in conjunction with the connectingelement to provide support for the cardiac element to apply constant,intermittent, or indirect pressure against the upper stomach and or GEjunction and lower esophagus. It is also to prevent the device frommigrating into the duodenum or small intestine. This pyloric elementwould be preferentially placed at or above the pyloric valve and couldbe in constant or intermittent contact with the pyloric region based onmovement of the stomach. Depending on the size relative to the stomach,this element may apply radial force, or contact force or pressure to thelower stomach which may also cause a satiety or neurohormonal response.Due to peristalsis of the stomach, the bariatric device may toggle backand forth in the stomach which may cause intermittent contact with theupper and lower stomach regions. The device may also have features toaccommodate for the motion to allow for constant contact with the upperand lower regions. Similar to the cardiac element, the pyloric elementcould take several different shapes such as a ring, a cone, afrusto-cone, a sphere, an oval, a pyramid, a square, a spiral, multipleprotuberances, multiple spheres or multiples of any shape or other. Itcould also be an inflatable balloon. This balloon could be spherical, orit could be a torus or a sphere with channels on the side to allow foodto pass, or it could be a cone, a portion of a cone or other shape. Thiselement may activate stretch receptors or a neurohormonal response toinduce satiety or another mechanism of weight loss by contacting orstretching certain portions of the stomach, to induce satiety, delayedgastric emptying or another mechanism of weight loss. The form andstructure of the cardiac and pyloric elements may vary to adaptappropriately for their purpose. For example, the cardiac element may bea ring while the pyloric element may be a cone or frusto-cone.

Some of the purposes of the connecting element are to connect thecardiac and pyloric elements, to provide structure for the device tomaintain its relative placement location, and to provide tension,pressure, or an outwardly biasing force between the pyloric and cardiacelements. The connecting element could take several different forms suchas a long curved wire, a curved cylinder of varying diameters, a spiralof a single diameter, a spiral of varying diameter, a ribbon, an I-beam,a tube, a taper, a loop, a curved loop or other. Similarly, theconnecting element could comprise multiple members to improve itsstructural integrity and positioning within the stomach. The connectingelement could be generally curved to match the greater curve or lessercurve of the stomach, both, or could be straight, or a combination ofany of the above. The connecting element could also be an inflatableballoon or incorporate an inflatable balloon.

The connecting and/or positioning elements 25, 13 could also beself-expanding or incorporate a portion that is self expanding. Selfexpansion would allow the element or a portion of the element to becompressible, but also allow it to expand back into its original shapeto maintain its function and position within the stomach, as well as thefunction and position of the other element(s). Self expansion wouldallow the elements to compress for placement down the esophagus, andthen expand its original shape in the stomach. This will also allow theelement to accommodate peristalsis once the device is in the stomach.This self-expansion construction of the connecting and positioningelements may impart an outwardly biasing force on the cardiac element,the pyloric element, or both.

In any of the embodiments disclosed herein, the device may bestraightened or collapsed for insertion down the esophagus, and thenreformed to the desired shape in the stomach to apply pressure at theupper and lower stomach regions or other regions as described above. Atleast a portion of the device could be made of a shape memory alloyssuch as Nitinol (nickel titanium), low density polyethylene or polymersto allow for it to compress or flex and then rebound into shape in thestomach. For placement of the device into the stomach, a flexiblepolymer tube, such as a large diameter overtube, could be placed downthe esophagus to protect the esophagus and stomach. The device couldthen be straightened and placed into the tube for delivery into thestomach, and then would regain its proper shape in the stomach once itexits the tube. Another variation for placement would be a customdelivery catheter to compress the device during placement and then allowthe device to deploy out of the catheter once in the stomach.

The bariatric device could be made of many different materials. Elementsof the device could be made with materials with spring properties thathave adequate strength to hold their shape after reforming, and/orimpart an outwardly biasing force. The materials would also need to beacid resistant to withstand the acidic environment of the stomach.Elements of the device could be made of Nitinol, shape memory plastics,shape memory gels, stainless steel, titanium, silicone, elastomers,teflons, polyurethanes, polynorborenes, styrene butadiene co-polymers,cross-linked polyethylenes, cross-linked polycyclooctenes, polyethers,polyacrylates, polyamides, polysiloxanes, polyether amides, polyetheresters, and urethane-butadiene co-polymers, other polymers, orcombinations of the above, or other suitable materials. For gooddistribution of stress to the stomach wall or to reduce contactfriction, the device could be coated with another material or could beplaced into a sleeve of acid resistant materials such as teflons, PTFE,ePTFE, FEP, silicone, elastomers or other polymers. This would allow fora small wire to be cased in a thicker sleeve of acid resistant materialsto allow for a better distribution of force across a larger surfacearea.

The device could take many forms after it reshapes.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 depicts a side view of a single wire embodiment the bariatricdevice of the present invention located within a cross-section of astomach.

FIG. 2 depicts a side view of an alternative single wire embodiment thebariatric device of the present invention located within a cross-sectionof a stomach.

FIG. 3 depicts a side view of an embodiment the bariatric device of thepresent invention located within a cross-section of a stomach.

FIG. 4 depicts a side view of a side view of an embodiment the bariatricdevice of the present invention located within a cross-section of astomach.

FIG. 5 depicts a side view of a side view of an embodiment the bariatricdevice of the present invention located within a cross-section of astomach.

FIG. 6 depicts a side view of a side view of an embodiment the bariatricdevice of the present invention located within a cross-section of astomach.

FIG. 7 depicts a side view of a side view of embodiment the bariatricdevice of the present invention located within a cross-section of astomach.

FIG. 8A depicts a side view of a side view of an embodiment thebariatric device of the present invention having a positioning element,located within a cross-section of a stomach.

FIG. 8B depicts a perspective view of a closeup of part of thepositioning element shown in FIG. 8A.

FIG. 9A depicts a side view of a side view of an embodiment thebariatric device of the present invention having a positioning element,located within a cross-section of a stomach.

FIG. 9B depicts a perspective view of a closeup of part of thepositioning element shown in FIG. 9A.

FIG. 10 depicts a side view of an embodiment the bariatric device of thepresent invention located within a cross-section of a stomach.

FIG. 11A depicts a side view of an embodiment the bariatric device ofthe present invention located within a cross-section of a stomach.

FIG. 11B depicts a side view of an embodiment the bariatric device ofthe present invention.

FIG. 12 depicts a side view of an embodiment of the bariatric device ofthe present invention located within a cross-section of a stomach.

FIG. 13 depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 14 depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 15 depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 16 depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 17 depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 18 depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 19 depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 20 depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 21 depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 22 depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 23A depicts a side view of a cross-section of a stomach,identifying anatomical features.

FIG. 23B depicts a side view of a cross-section of a stomach showing itsapproximate shape when undergoing contractions due to peristalsis.

FIG. 24 depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 25 depicts a side view of the embodiment of the present inventionshown in FIG. 24, located within a cross-section of a stomach that isundergoing contraction due to peristalsis.

FIG. 26 depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 27 depicts a side view of the embodiment of the present inventionshown in FIG. 26, located within a cross-section of a stomach that isundergoing contraction due to peristalsis.

FIG. 28 depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 29 depicts a side view of the embodiment of the present inventionshown in FIG. 28, located within a cross-section of a stomach that isundergoing contraction due to peristalsis.

FIG. 30 depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 31 depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 32A depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 32B depicts an internal end view of a pyloric element of anembodiment of the bariatric device of the present invention, locatedwithin a cross-section of a stomach shown in FIG. 32A.

FIG. 33A depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 33B depicts an internal end view of a pyloric element of anembodiment of the bariatric device of the present invention, locatedwithin a cross-section of a stomach shown in FIG. 33A.

FIG. 34A depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 34B depicts an internal end view of a pyloric element of anembodiment of the bariatric device of the present invention, locatedwithin a cross-section of a stomach shown in FIG. 34A.

FIG. 35 depicts a side view of the embodiment of the present inventionshown in FIG. 34A, located within a cross-section of a stomach that isundergoing contraction due to peristalsis.

FIG. 36A depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 36B depicts a side view of the embodiment of the present inventionshown in FIG. 36A, located within a cross-section of a stomach that isundergoing contraction due to peristalsis.

FIG. 37A depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 37B depicts a side view of the embodiment of the present inventionshown in FIG. 37A, located within a cross-section of a stomach that isundergoing contraction due to peristalsis.

FIG. 38A depicts an underside perspective view of an embodiment of thebariatric device of the present invention.

FIG. 38B depicts a top view of an embodiment of the bariatric device ofthe present invention.

FIG. 39A depicts an underside perspective view of an embodiment of thebariatric device of the present invention.

FIG. 39B depicts a top view of an embodiment of the bariatric device ofthe present invention.

FIG. 40A depicts a side view of a pyloric element of an embodiment ofthe present invention.

FIG. 40B depicts a side view of a pyloric element of an embodiment ofthe present invention.

FIG. 41 depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 42A depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 42B depicts a side view of a connecting element of an embodiment ofthe present invention.

FIG. 42C depicts a side view of a connecting element of an embodiment ofthe present invention.

FIG. 42D depicts a side view of a connecting element of an embodiment ofthe present invention.

FIG. 43 depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 44A depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 44B depicts an underside perspective view of an embodiment of thepresent invention.

FIG. 45A depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 45B depicts an underside perspective view of an embodiment of thepresent invention.

FIG. 46A depicts a side view of strap retainer of an embodiment of thepresent invention.

FIG. 46B depicts a side view of strap retainer of an embodiment of thepresent invention.

FIG. 46C depicts an end view of strap retainer of an embodiment of thepresent invention.

FIG. 46D depicts an end view of strap retainer of an embodiment of thepresent invention.

FIG. 46E depicts a top view of strap retainer retaining a member withtwo positional beads of an embodiment of the present invention.

FIG. 47A depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 47B depicts a side view of a retainer strap and clip adjustmentmechanism of an embodiment of the present invention.

FIG. 47C depicts a side view of a retainer strap and clip adjustmentmechanism of an embodiment of the present invention.

FIG. 47D depicts a side view of a retainer strap and clip adjustmentmechanism of an embodiment of the present invention.

FIG. 48 depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 49A depicts an end view of a retainer clip in a relaxed and closedstate, and a bead on a member shown in cross section, of an embodimentof the present invention.

FIG. 49B depicts an end view of a retainer clip shown in FIG. 49A in acompressed and open state, and a bead on a member shown in crosssection.

FIG. 50A depicts an end view of a retainer clip in a relaxed and closedstate, and a bead on a member shown in cross section, of an embodimentof the present invention.

FIG. 50B depicts an end view of a retainer clip shown in FIG. 50A in acompressed and open state, and a bead on a member shown in crosssection.

FIG. 51A depicts an end view of a keyway, and a bead on a member shownin cross section, of an embodiment of the present invention.

FIG. 51B depicts an end view of a keyway shown in FIG. 51A, and a beadon a member shown in cross section that has translated its positionrelative to FIG. 51A.

FIG. 52A depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 52B depicts an underside perspective view of an embodiment of thepresent invention.

FIG. 53 depicts a side view of an embodiment of the present inventionhaving an adjustment mechanism in the pyloric element, located within across-section of a stomach.

FIG. 54 depicts an end view of the adjustment mechanism in the pyloricelement of the embodiment shown in FIG. 53.

FIG. 55 depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 56 depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 57 depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 58A depicts a side view of an embodiment of the present invention,having an adjustment mechanism in the pyloric element in an uninflatedstate, located within a cross-section of a stomach.

FIG. 58B depicts a side view of the embodiment shown in FIG. 58A, havingan adjustment mechanism in the pyloric element in an inflated state,located within a cross-section of a stomach.

FIG. 59 depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 60 depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 61A depicts a side view of an embodiment of the present invention,with a magnetic adjustment mechanism in cross section view, locatedwithin a cross-section of a stomach.

FIG. 61B depicts a closeup cross-section view of the magnetic adjustmentmechanism shown in FIG. 61A, next to a controller magnet.

FIG. 62 depicts a side view of an embodiment of the present invention,equipped with adjustment cones in the pyloric element shown in crosssection, located within a cross-section of a stomach.

FIG. 63 depicts a cross-section view of an alternative embodiment of theadjustment cone shown in FIG. 62.

FIG. 64 depicts a cross-section view of an alternative embodiment of theadjustment cone shown in FIG. 62.

FIG. 65 depicts a side view of an embodiment of the present invention,equipped with adjustment mechanism shown in cross section, locatedwithin a cross-section of a stomach.

FIG. 66 depicts a remote controller of an embodiment of the presentinvention, worn next to the user's body.

FIG. 67 depicts a remote controller of an embodiment of the presentinvention, used without wearing or placing adjacent to the body.

FIG. 68 depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 69 depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach.

FIG. 70 depicts a side view of an embodiment of the bariatric device ofthe present invention, located within a cross-section of a stomach and aduodenum.

FIG. 71A depicts a side view of an adjustment mechanism in an unexpandedstate, of an embodiment of the present invention.

FIG. 71B depicts a side view of an adjustment mechanism shown in FIG.71A, in an expanded state.

FIG. 72A depicts a side view of an adjustment mechanism in an unexpandedstate, of an embodiment of the present invention.

FIG. 72B depicts a side view of an adjustment mechanism shown in FIG.72A, in an expanded state.

FIG. 73A depicts a side view of an adjustment mechanism in an unexpandedstate, of an embodiment of the present invention.

FIG. 73B depicts a side view of an adjustment mechanism shown in FIG.73A, in an expanded state.

FIG. 74 depicts a side view of a delivery sheath containing a medicaldevice.

FIG. 75 depicts a side view of the delivery sheath shown in FIG. 74,partially opened to show an expanded medical device.

FIG. 76 depicts a side view of an embodiment of a stomach measurementdevice.

FIG. 77 depicts a side view of an embodiment of a stomach measurementdevice showing the frusto-conical member in an inflated state.

FIG. 78 depicts a closeup side view of the stomach measurement deviceshown in FIG. 77, showing the frusto-conical member in a deflated state.

FIG. 79 depicts a perspective view of a pyloric element equipped with aconstriction element, in an embodiment of the present invention.

FIG. 80 depicts a perspective view of the pyloric element shown in FIG.79, with the constriction element engaged to constrict the pyloricelement.

FIG. 81A depicts a perspective view of a pyloric element equipped with aconstriction element with a mechanical stop, in an embodiment of thepresent invention.

FIG. 81B depicts a perspective view of a pyloric element equipped with aconstriction element with a mechanical stop, in another embodiment ofthe present invention.

FIG. 82 depicts a perspective view of the pyloric element shown in FIG.81B, with the constriction element engaged to constrict the pyloricelement.

FIG. 83 depicts a cross-section view of an embodiment of a bariatricdevice within the scope of the present invention showing a pyloricelement with a valve passing across the midsection of the pyloricelement to slow down the passage of food.

DETAILED DESCRIPTION OF THE INVENTION

The detailed description set forth below in connection with the appendeddrawings is intended as a description of presently-preferred embodimentsof the invention and is not intended to represent the only forms inwhich the present invention may be constructed or utilized. Thedescription sets forth the functions and the sequence of steps forconstructing and operating the invention in connection with theillustrated embodiments. It is to be understood, however, that the sameor equivalent functions and sequences may be accomplished by differentembodiments that are also intended to be encompassed within the spiritand scope of the invention.

The most basic embodiment of the bariatric device 10 may have a singlepiece of Nitinol wire 11 which is shape set into a shape, but can bepulled under tension into a generally narrow and straight form, to allowfor insertion of the device 10 through the esophagus. In such anembodiment, the elements may all be seamlessly integrated as one wirestructure. See FIGS. 1 and 2. Depending on the size of the stomach, theshape set wire may impart an outwardly biasing force to the proximal anddistal elements of the bariatric device 10, which may vary duringperistalsis.

As for the two-element embodiment (cardiac element 12 and positioningelement 13), when tension to stretch the device 10 is released, it maycoil into a ring, cone or spiral at one end near the upper stomach orcardia, and curve into a shape to relatively match the lesser andgreater curve of the stomach 16, 17 and be of sufficient size to notmigrate across the pyloric valve 18 into the duodenum 19. See FIGS. 3and 4. The positioning element 13 could also have a straighter sectionthat does not follow the lesser curve 16, but does follow the greatercurve 17. See FIG. 5. In this embodiment, the positioning element 13could also be in a different plane such that is perpendicular to thatshown in FIGS. 3, 4, and 5, or the device 10 could contain multiplemembers that were in the same plane and perpendicular to the plane shownin FIGS. 3, 4, and 5. To use a plane perpendicular, the element couldfollow the midline of the stomach between the greater and lesser curves17, 16, and would contact the posterior and anterior walls of thestomach.

As noted above, the cardiac element 12 may be in the form of a ring,which can be formed from a single Nitinol wire 11, or a wide variety ofother suitable materials, such as silicone, Nitinol encased in silicone,etc. Preferably, the ring can be compressed or collapsed for insertionthrough the esophagus, then regain or reform its shape after placementin the stomach. The ring could lock or not lock after forming, or couldbe continuous prior to placement. A variation may have the ring closed,locked, or continuous prior to placement down the esophagus. See FIG. 4.The ring could be compressed enough to fit within a placement tube ordelivery catheter for placement through the esophagus. The cross-sectionof the ring could be round, flat, oval, convoluted, wavy or knobby toadd pressure points that continuously move to stimulate the upperstomach or cardia during peristalsis and reduce the potential foroverstressing a certain area. See FIG. 6. The cardiac element 12 couldalso be a cone of flexible material or combinations of materials. SeeFIG. 7. The device 10 need not be fixed into place but may be moveablewithin the stomach. Once the device 10 is placed, preferably, it isgenerally self-seating to ensure that it sits in the correct generalareas similar to the way a contact lens re-seats itself on the corneaeven after it is moderately pushed off center. Since the stomach isnonsymmetrical, the device 10 could be formed to have a bias to ensurethat it seats into the upper stomach or cardia and within the lowerstomach as needed. Similarly, the action of peristalsis would createadditional satiety signals to be sent each time a wave passes by thedevice 10 it could slip around in the stomach varying the pressureplaced on the upper and lower stomach over time pending the force ofperistalsis.

The positioning element 13 could comprise two or more positioningmembers 20. For example, a member 20 could follow the curve of thegreater curve 17 and the other member 20 could provide the supportbetween the first member and the cardiac element 12. To further improvethe design, the two members 20 of the positioning element 13 couldarticulate and or rotate relative to one another to accommodate for themovement of the stomach. See FIGS. 8A, 8B, 9A and 9B. As shown, thepositioning element 13 could also contain a pyloric feature 21 thatcould translate along the great curve in the pyloric region 42 andprevent the device 10 from passing through the pyloric valve 18. Anothervariation for the positioning element 13 with multiple members would beto have a member that is a loop 22 and is attached to a member with asupport that follows the greater curve 17. See FIG. 10. The loop member22 could flex in shape to change in length and width to accommodate forthe stomachs movement during peristalsis. The positioning member couldalso be a spiral spring 23 or spring plunger assembly 24. See FIGS. 11Aand 11B. This member could also have a manual mechanism for adjustingthe maximum length, such as having a set screw block the distance thatthe plunger could travel. Details on various adjusting mechanisms arediscussed below.

The positioning element 13 could also be a spiral or spring, or multiplespirals or multiple springs to create a flexible structure. See FIG.11B. The positioning element 13 could also be bisected into two membersthat stack, telescope or articulate, such as those shown in FIGS. 8A-9B.The positioning element 13 could also have a joint such as a ball andsocket type joint 29 or may be connected by magnets. As mentioned above,these devices could also contain an additional positioning element 13that is in a plane perpendicular or other angle to that shown in thefigures, so that the positioning element 13 contacts the midline of thestomach between the greater and lesser curves 17, 16, and contacts theposterior and anterior walls of the stomach.

In any of the embodiments discussed herein, the positioning and/orconnecting elements 13, 25 may be constructed of materials, or in such amanner, that may impart an outwardly biasing force, to push on thecardiac and/or positioning or pyloric elements. Such outwardly biasingforce may impart constant or intermittent pressure to various parts ofthe stomach, through the cardiac element 12, the pyloric element 26, thepositioning or connecting elements 13, 25, or any combination thereof.

In the three-element embodiment (cardiac, pyloric, and connectingelements 12, 26, 25), the three elements may all be seamlesslyintegrated as one wire structure. When tension to flex, compress orstretch the device 10 is released, it may coil into a ring or loop nearthe cardia 40, and coil into a ring or loop near the pyloric region 42,with a curved member to connect the two elements that is shaped torelatively match the greater curve 17 of the stomach. The curve couldalso match the lesser curve 16 of the stomach or both. See FIGS. 12 and13. The connecting element 25 could curve into a single ring, or itcould curve into a spiral. See FIG. 14.

As in other embodiments, the rings at each end could lock or not lockafter forming, the rings may be closed, locked or continuous prior toplacement down the esophagus, and could be compressed enough to fitwithin a placement tube for placement through the esophagus. See FIGS.12 and 13. As with other embodiments, the elements of the bariatricdevice 10 may have a variety of shapes to add pressure points thatcontinuously move to stimulate the cardiac region 40 during peristalsis.See FIGS. 15, 16, and 17. The device 10 need not be fixed into place butmay be moveable, and generally self-seating. The device 10 may have abias to fit the nonsymmetrical stomach shape and ensure that it seatsinto the cardiac region 40 and pyloric region 42. Similarly, the actionof peristalsis could create additional satiety signals as the device 10moved in the stomach varying the pressure placed on the cardiac region40 and/or the pyloric region 42 over time.

In the three-element design shown in FIG. 12, the connecting element 25connecting the two rings could follow the natural curve of the stomachto match the greater or lesser curve of the stomach 17, 16, or couldhave both. This would aid in the seating of the device 10 in the stomachafter placement. The connecting element 25 could have one or moreconnecting members 30 connecting the cardiac and pyloric elements 12,26. See FIG. 13. However, these members 30 should be flexible enough toallow for natural peristalsis to occur, natural sphincter function tooccur and to not cause erosion or irritation of the stomach wall orsignificant migration into the esophagus or duodenum 19. There couldalso be struts or supports that help to support the geometric shape ofthe rings to the connecting element 25. The connecting element 25 couldalso be a spiral 28 or multiple spirals to create a flexible structure.See FIG. 14. The connecting element 25 could also be bisected into twomembers that stack, telescope or articulate. The connecting element 25could also have a joint such as a ball and socket type joint 29 or maybe connected by magnets. See FIG. 18.

In another variation of the embodiments, there could be several rings 31at each end of the device 10 to create an area of pressure at the upperstomach or cardia 40. See FIG. 19. The rings 31 should be sizedappropriately to ensure that they do not protrude or slip into theesophagus 32 or into the duodenum 19, unless a variation of thisembodiment is designed to have some portion of the device 10 enter thoseregions. This will allow the device 10 to apply pressure to the upperstomach or cardia 40 without fixation or sutures. The force against thepyloric region 42 and/or lower stomach will provide the counterforceagainst the upper stomach or cardia 40. At the same time, the force orcontact against the pyloric region 42 and/or lower stomach may signalthe body to stop eating. This force would mimic having a meal in thestomach with subsequent peristalsis, and sending the signal to stopeating. The multiple rings 31 could take the form of a spiral or couldbe separate rings 31 connected together. After reforming in the stomach,the rings 31 could lock, not lock, or be continuous. There are severalways that these elements could lock to form a ring.

Another option for the cardiac element 12 would be to have a surfacethat contacts the upper stomach or cardia 40 such as a hemispherical orconical shaped shell 33 or balloon. The shape could also be asymmetricalbut similar to a cone or hemisphere. This could be a thin walled elementand could contain a lumen or no lumen through which food could pass. SeeFIG. 20. In the case where there is no opening, the food would have topass over the hemisphere or cone 33 which would have adequateflexibility to allow the food to pass into the stomach. This may requirethe esophagus 32 to work harder to pass the food over the element andcould better stimulate the stretch receptors in the stomach andindirectly in the esophagus. In another alternative, the hemisphericalshell 33 could have multiple grooves or channels to aid in allowing foodto pass. In the case where there is a lumen in the cardiac element 12,it could be open or it could have a valve 35 that requires some force toallow food to pass through. An option could also be to have anesophageal member 36 that extends into the esophagus 32 for additionalesophageal stimulation. This esophageal member 36 could be tethered by athin structural member to support the esophageal member 36, but notprevent the esophageal sphincter from closing. As mentioned above, thismay require the esophagus 32 to work harder to pass the food and maybetter stimulate the stretch receptors in the stomach and indirectly inthe esophagus. This esophageal member 36 could be a large tube, a smalltube, a ring, a small sphere, multiple small spheres, or other suitableshapes. This type of embodiment could also be adapted for the 2 elementdesign, where the cardiac element 12 is connected to a positionalfeature as shown in FIG. 21. All aspects of the above embodiment wouldapply towards this embodiment as well.

The pyloric element 26 could contain a lumen or could contain a valvesimilar to the valve shown in FIG. 20 for the cardiac element 12. Thiscould reduce the speed of food passing through the pyloric element 26 ifdesired. This valve 35 could be a thin membrane of silicone with asingle or multiple slits punch through the center, or other types ofvalves could be used. FIG. 83 shows a pyloric element with a valve 35passing across the midsection of the pyloric element 26 to slow down thepassage of food.

The connecting element could also be an inflatable balloon 104 orincorporate an inflatable balloon. FIG. 83 depicts a connecting element25 that could be comprised of an inflatable balloon 104. This inflatablebody 104 could be compressed for placement and then inflated with afluid to provide structure and adjustability after placement in thestomach. An inflation element 74 such as an injection port may beattached to the balloon where an instrument could be used to add orremove fluid to the inflatable balloon 104. The positioning element 13could also contain or comprise an inflatable balloon.

With respect to the three-element design, another alternative embodimentfor the pyloric element 26 would be to change the orientation to allowthe axis of the loop 37 to be perpendicular to the axis of the pyloricvalve 18 similar to some embodiments described for the two-elementdesign. This may simplify manufacturing construction yet perform thesame function. In such an embodiment, the pyloric element 26 could havethe loop in a single plane, two crossed planes, or multiple planes. SeeFIG. 22.

As mentioned above, the stomach experiences peristaltic waves whensomething is swallowed. FIG. 23A depicts a stomach cross-section showingthe Z line and gastroesophageal (“GE”) junction 38, the cardia orcardiac region 40, the fundus 41, the pyloric region 42, the pyloricantrum 43, the pyloric valve 18, and the duodenum 19. FIG. 23B depictsthe stomach's lesser curve 16 and greater curve 17. FIGS. 23A and 23Brespectively show a representation of the stomach profile when thestomach is at rest and when the stomach is fully contracted duringperistalsis and the change in stomach diameter and length. Due to thechange in stomach profile, it may be advantageous to have a design thatcan flex to change with the stomach profile to allow the design to slideor translate along the greater curve 17 or flex as needed, but maintainthe relative position of the cardiac element 12. As mentioned above, thetwo-element device 10 could also contain a member or an additionalpositioning element 13 that is in a plane perpendicular or other angleto that shown in the figures, so that the element contacts the midlineof the stomach between the greater and lesser curves 17, 16, andcontacts the posterior and anterior walls of the stomach. This wouldmaintain the position within the stomach with less flex needed tomaintain the position with the greatest motion taking place along thegreater curve 17, and least motion taking place along the lesser curve16.

FIGS. 24 and 25 show an alternate embodiment of the two-element designto adapt to stomach profile changes. In FIG. 24, it shows the cardiacelement 12 engaging the upper stomach region while the positioningelement 13 is a spring with two closed loops 44 at each end which cancompress and flex to accommodate peristalsis within the stomach. FIG. 25shows these loops 44 compressing during peristalsis to allow the device10 to maintain its relative position in the stomach and preventing itfrom migrating past the pyloric valve 18.

FIGS. 26 and 27 show an alternate embodiment of the two-element designwhere the positioning element 13 is a spring with open loop 45 where theloops 45 are allowed to flex as needed to maintain the relative positionof the device 10 within the stomach. A mechanical stop for maximumcompression is supplied by only allowing the spring to flex until theloop 45 has closed. This ensures that a minimum profile is maintained toprevent the device 10 from potentially migrating past the pyloric valve18 and into the duodenum 19.

FIGS. 28 and 29 show another alternate embodiment of the two-elementdesign where the cardiac element 12 is in the form of a spiral and thepositioning element 13 is a closed loop 46. The closed loop 46 isallowed to compress as needed during peristalsis to maintain itsrelative position. This also shows a mechanical stop 47 that could beadded inside the loop to prevent the loop from over flexing. The cardiacelement 12 could also be a sphere as shown or ring as shown in otherfigures.

FIG. 30 shows a device 10 similar to one shown in FIG. 8A where thepositioning element 13 contains two members 20. One member 20 couldcontain a loop that could intermittently engage the pyloric region 42 toprevent undue migration.

Another alternative to this design would be to have a connecting element25 made up of two members 30 that can slide relative to one another toaccommodate for stomach motion. See FIG. 31. This drawing shows how aflexible wire or ribbon, the connecting element 25, could fit inside ofless flexible pre-curved pyloric element 48. As the stomach contracts,the connecting element 25 could slide or into the pre-curved pyloricelement 48 to reduce the overall length during stomach contraction.Since the connecting element 25 would resist the permanent curvature, itwould spring back out of the pre-curved pyloric element 48 to regain itslength when the contraction was completed.

Another embodiment to accommodate for stomach contractions would allowthe pyloric element 26 to flex and slide along the lower stomach regionor pyloric region 42. In this embodiment, the pyloric element 26 andconnecting element 25 could be combined into a single member. Thepyloric element 26 could be a flexible ribbon with an open curve in theend. This curve could flex to create a closed loop which would allow thedevice 10 to slide within the lower stomach segment to maintain theposition of the cardiac element 12 and not migrate beyond the pyloricvalve 18.

In yet another embodiment, the connecting element 25 may be made up oftwo or more members 30. See FIGS. 32A and 32B. As shown in the drawing,the cardiac element 12 would contact the upper stomach or cardiac region40, while pyloric element 26 contacts the lower stomach or pyloricregion 42. The connecting element 25 has three members 30, which areshown as curved wires or ribbons. One member 30 curves to match thelesser curve 16 (LC), while two other members 30 curve to match a medianline between the lesser and greater curve 17 (GC), and curve to contactthe anterior and proximal surfaces of the stomach to maintain itsposition even during peristalsis. FIG. 32A shows an optional locationfor the pyloric element 26 in the pyloric region 42. FIGS. 33A and 33Bshows a similar embodiment with another optional location for thepyloric element 26 closer to the pyloric valve 18.

In another embodiment, peristaltic motion may cause the device 10 tomove inside the stomach and could cause the pyloric element 26 to slidefrom the relative locations such as those shown in FIGS. 34A, 34B and35. These drawings show a three-element embodiment where the connectingelement 25 may have four members 30. FIGS. 34A, 34B and 35 depict asimilar embodiment to FIGS. 33A and 33B, but with an additional elementto match the greater curve 17. During peristalsis, the greater curve 17will shorten, and the member 30 that matches could curve inward to aconvex form. After the peristaltic action is complete, the member 30 mayspring back to its original concave form. Using these concepts,additional members 30 for the connecting element 25 may be used beyondthe three and four members 30 described here, and could be located in avariety of locations along the midline, lesser curve 16 or greater curve17 or any combination.

FIGS. 36A and 36B depict an embodiment where the cardiac element 12 maybe allowed to intermittently contact the upper stomach duringperistalsis. The pyloric element may be a rigid or semi-rigid ring 49and the connecting element 25 may be a spring to connect to the cardiacelement 12. In this embodiment, the ring 49 could engage the lowerstomach at a fixed diameter when the stomach is at rest. Compression ofthe stomach during peristalsis would push the ring 49 towards the upperstomach to allow the cardiac element 12 to intermittently contact theupper stomach and/or cardiac area 40. This may be advantageous toprevent overstimulation of the upper stomach or for other purposes.

In yet another set of embodiments, the bariatric device 10 in either thetwo- or three-element embodiments may be self expanding. FIGS. 37A and37B depict an alternative embodiment where the cardiac and pyloricelements 12, 26 are self expanding. These elements could be selfexpanding or have a portion that is self expanding to allow the device10 to flex with peristalsis, but maintain tension to spring open toapply pressure or contact and position within the stomach. The selfexpanding portion could be made of Nitinol, silicone, polyurethane,Teflons, stainless steel or other suitable materials or combinations ofsuitable materials. FIGS. 37A and 37B shows a Nitinol wire mesh pattern50 applied to a frusto-conical shape to create a shell. The Nitinol wiremay act as a stiffening member within the cardiac and pyloric elements12, 26. The Nitinol wire could be arranged in many different patterns toallow for the appropriate amount of self expansion while allowing theelement to compress during peristalsis. The array pattern could includecircular arrays, angular arrays, linear arrays, or other suitablearrays. The pattern could be woven or a continuous spiral.

The self expanding function may also assist in deployment by allowingthe device 10 to compress and then regain its shape. A preferred methodof deployment is to compress the bariatric device 10 into a long narrowshape, which is then placed in a deployment tube, sheath or catheter.The collapsed and encased device 10 is then guided down the patient'sesophagus 32 and into the stomach, where the bariatric device 10 isreleased from the deployment tube or catheter. Once released, the device10 would expand to its original operational shape. The stiffeningmember, such as Nitinol wire, may provide adequate stiffness to expandthe elements into their operational shape, and maintain that generalshape during operation, while allowing flexibility to accommodateperistalsis.

The embodiment depicted in FIGS. 37A and 37B show the cardiac andpyloric elements 12, 26 connected by a connecting element 25 withmultiple curved members, which are shown to be a wire mesh array 50, butcould be made of Nitinol wire, silicone, teflon another suitablematerial, or a combination of these materials. The four members of theconnecting element 25 have different lengths to allow for properalignment and seating within the stomach. FIG. 37B depicts how duringperistalsis, the stomach will contract and its profile will reduce. Thebariatric device 10 may shift and flex within the stomach, but the selfexpansion feature allows it to spring open and maintain its generalposition correctly. The connecting element 25 could have a pre-curvedbend to form a living hinge to direct where the element to flex duringperistalsis as shown in 37B.

As shown in FIGS. 37A and 37B, a preferred embodiment of the cardiacelement 12 may be a substantially flattened frusto-conical shape,defining a substantially circular opening that is adapted to correspondto the esophageal/cardiac opening of a stomach. Those figures also showthat a preferred embodiment of the pyloric element 26 may be a steepfrusto-conical shape, or a tapered cylinder, which is adapted to fit thepyloric region 42 of the stomach, and preferably sized so that it doesnot migrate past the pyloric valve 18. As discussed above, theseelements may have a wide variety of shapes or may be inflatable, andthese are only examples

The four connecting members may be constructed from 2 full loops or 2loops connected together to create a “FIG. 8” structure. The loops couldbe contoured to generally follow the curves of the stomach, and could beconnected to the pyloric and cardiac elements 26, 12 in a variety oflocations. The loops could be oriented to intersect at a variety oflocations to provide different configurations with varying structuralresistance and flexure points. For example, FIGS. 38A and 38B depict abariatric device 10 where there are 2 separate closed loops 51 and theloops 51 are crossed in the pyloric element 26 so that the wires do notobstruct the distal opening of the element. The loops 51 are thenaligned in a parallel pattern where they are attached to the cardiacelement 12. This allows the cardiac element 12 to follow the contours ofthe loops 51 even when the device 10 is laid flat and the loops 51 arecompressed together as could be the case inside the stomach. This couldallow for more uniform curved contact of the cardiac element 12 with thecardia 40 and adjacent fundus 41. The parallel orientation of the loops51 along the cardiac element 12 would provide less resistance of thedevice 10 just below the GE junction for a more gentle response.

In another embodiment, the 2 loops 52 are connected in a “FIG. 8”pattern where the loops are 52 crossed in the pyloric element 26 and donot obstruct the distal opening of the pyloric element 26. See FIG. 39.The loops 52 cross again just below the opening of the cardiac element12, which allows the cardiac element 12 to flare more when the device 10is laid flat and the loops 52 are compressed together such as could bethe case inside the stomach. This could allow for more focused, linearcontact of the cardiac element 12 with the cardia 40 and adjacent fundus41 in the stomach. The cross of the loops 52 below the opening of thecardiac element 12 would provide more structural strength of the device10 just below the GE junction 38 for more acute response. To increasethe acute response, a stiffening member such as a wire loop or othercould be added cardiac element 12 to direct stiffness in a desired area.FIG. 39 shows one possible orientation for a stiffening member, butother orientations, shapes and additional members could be added togenerate a specific response.

Where the connecting element 25 is formed from loops, the loops could beformed from Nitinol wire and then coated in an acid-resistant coating 53such as silicone or silicone covering. These loops could also be made ofstainless steel, teflons or other suitable materials or combinations ofmaterials. The loops could be closed or connected in a variety of ways.For the example of Nitinol, the loops could be closed by a glue jointwhere the wire loop ends are glued inside of another tube. They couldalso be closed by a crimping, swaging, or welding. The loops could alsobe left open, if a feature is added for adjustability and it ispreferred to have the loops open with both ends fixed to the elements asneeded.

The contact members of the elements may be comprised of a variety ofmaterials. For example, the Nitinol wire pattern of the cardiac,pyloric, and or connecting and/or positioning elements 12, 26, 25, 13may be exposed for direct contact with the stomach or the wire could becovered or sealed in another material, such as silicone, PTFE,polyurethane or other suitable materials. For example, FIG. 40A depictsa pyloric element 26 where the wire mesh 50 is covered in anothermaterial to create a smooth surface for the contact member 54 tofacilitate sliding within the stomach. Alternatively, FIG. 40B shows thewire exposed to the stomach mucosa surface. This shows how the wirearray 50 could be arranged and formed to add a wavy pattern to increaseto profile of the wire above the element's nominal surface, which inthis case is shown as a cone with the wire protruding above the conessurface. This would allow the wire to act as a macro texture surface forthe contact member 54 to grip the stomach surface to reduce sliding orit could provide a macro texture for tissue ingrowths. The Nitinol maybe treated with a surface finish, passivation or coating to improve itsacid resistance within the stomach.

The contact and stiffening members of the elements may be separate,entirely integrated, or both. For example, if a cardiac element 12 ismade entirely of Nitinol wire, the wire acts as both a contact memberand a stiffening member. The same would apply if an element were madeentirely of silicone; the silicone would act as both a stiffening andcontact member. In another embodiment, where Nitinol wire is embedded inanother material such as silicone, the Nitinol wire acts as a stiffeningmember and the silicone acts as a contact member. In another embodiment,the Nitinol wire may be partially exposed and partially covered by thesilicone (and/or on the interior of the element), in which case theNitinol wire acts as both a stiffening and contact member. In certainembodiments, the combination of materials may act as a stiffeningmember. For example, an embodiment where the contact member is siliconewith Nitinol wire embedded, the silicone may act in conjunction with theNitinol to provide more stiffness than the Nitinol could achieve alone.Various combinations of stiffening and contact members may be apparentto those skilled in the art.

Yet another embodiment with self expanding features is depicted in FIG.41. In this embodiment, the cardiac, pyloric, and connecting elements12, 26, 25 are all combined into a single unit, which contours to followthe general shape of the stomach but designed to maintain outwardlybiasing pressure at upper and lower stomach regions. The self expansionfeature will allow the device 10 to flex and give during peristalsis,but would allow the device 10 to spring open to maintain its positionand function. The wire array 55 could be designed to encourage moreexpansion in one area than in another, or be stiffer in one area oranother, to further improve the function of the device 10.

Yet another embodiment with self expanding features is depicted in FIG.42A, where the cardiac, pyloric, and connecting elements 12, 26, 25 allhave self expanding portions. The cardiac and pyloric elements 12, 26are generally frusto-conical in shape and contain a Nitinol wire pattern50 for radial and longitudinal expansion. The connecting element 25 isalso self expanding and connects the cardiac and pyloric elements 12,26. The connecting element 25 can compress and expand to maintain andappropriate amount of pressure on the upper and lower stomach and tomaintain the device 10's position. The connecting element 25 could bejust a bare Nitinol wire array 50 or it could be covered with siliconeor other suitable material(s). As described for previous embodiments,the connecting element 25 could match the greater or lesser curve 16, orgo down the center of the stomach or be a combination of both. Coveringthe device 10 with another material could constrain the compressibilityof the length of the device 10, which may be desirable in order toachieve pressure and/or contact at various portions of the stomach.There may also be another member down the center of the Nitinol tubulararray 56 to increase stiffness and to adjust the length. FIG. 42B showsthe connecting element 25 made up of a wire array 56 at rest. FIGS. 42Cand 42D show how the length of this element 25 may be adjusted toelongate the length. Adjustability of the length would allow the device10 to be adjusted to custom fit the device 10 to the patient. FIG. 42Cshows how an additional ring or feature 57 could be applied to theoutside of the tube to reduce the diameter and increase the length. FIG.42D shows how a pin or clip 58 may be placed inside the mesh array 56 toincrease the length which subsequently would reduce the diameter. Theseadjustability features could be applied to any of the self expandingfeatures.

FIG. 43 shows a similar embodiment to above but shows that theconnecting element 25 could contain multiple self expanding members 59.This figure shows one member 59 along the lesser curve 16 and twomembers 59 along the midline between the lesser and greater curves 16,17, which contact the anterior and posterial surfaces of the stomachwalls. These could all contain expansion features as mentioned above.Although FIG. 43 depicts three members 59 in the connecting element 25,it could contain two, four, or any number of members. These memberscould match the lesser curve 16, greater curve 17, stomach midline orall any combination of these.

As mentioned above, a preferred device 10 has adjustability oradaptability to match any changes in the patient over time. A variationof the above embodiments would be to allow the device 10 to beadjustable via an adjustment element 60. This adjustability could be inthe length, shape, angle or stiffness of the cardiac, pyloric,connecting, and/or positioning elements 12, 26, 25, 13.

The bariatric device 10 could be adjustable to allow for adjustment atthe time of placement or could be adjusted at a later time. Thisadjustability could be achieved by having a variable spring tension inone of the elements to allow the device 10 to extend, contract, ordistort as needed. It could also be achieved by adding an expansionjoint 75 in a member to elongate or compress as needed. This expansioncould be a manual adjustment performed by the physician in the officethrough a gastroscopic procedure. This expansion could be achieved byvarious mechanisms, including but not limited to those operated by:rotating a threaded member, ratcheting backwards or forwards, ahydraulic mechanism, a pneumatic mechanism, a cam, a tension mechanism,a telescoping mechanism or other elongation or contraction mechanisms.The outer surface of the connecting element 25 and/or positioningelement 13 is preferably smooth with rounded or gently angled edges toprevent irritation of the stomach during peristalsis, although sharpangles may be preferred in some applications. To create a smoothinterface, these elements could be encased in a sleeve or sheath thatcould be removed or remained fixed during the expansion. A sheath maynot be required if the expansion joint 75 is designed with smoothcontours on its own.

Manual Actuation

The device 10 could also be adjusted by manual means inside the stomachby using a gastroscopic instrument to come into direct contact with thedevice 10.

-   -   The instrument could also act as a pusher or puller to activate        a pulley mechanism or a clipping mechanism. For example, the        positioning and/or connecting element 13, 25 could be a ratchet        or strut with multiple positional features such as holes,        grooves, teeth or wedging action. The device 10 could have a        feature to engage the ratchet teeth or positional features such        as a pin or clip or other. The instrument could retract the pin        or compress the clip and then reposition this feature in the        next available location.        -   In another embodiment, the members of the connecting element            25 could have multiple beads or spheres 62 that are captured            by a cuff or ring retainer on the cardiac element 12. An            instrument could be used to expand the cuff to pull the bead            through for positioning. Similarly, the cuff could have a            keyway retainer feature that allows the bead to only fit            through a specific location and then lock into position            where the beads connect to the wire or ribbon or tube.        -   FIGS. 44A and 44B, shows a similar feature in the pyloric            element 26 where the adjustment element 60 is a single wire.            FIGS. 45A and 45B shows an adjustment element 60 in the            pyloric element 26 where there could be a full loop 64 that            has expansion features on both sides of the loop 64. These            features could be beads or clips 62 that can be pulled            through a mechanical feature such as a hole or strap            retainer 63 and held in place. FIGS. 46A, 46B, 46C, 46D, and            46E show side views and top views of optional retaining            features 63 that allow for expansion to let a bead or            arrowhead 62 pass, but then close to hold the feature in            position.        -   FIGS. 47A, 47B, 47C and 47D shows several examples of            compressible clips 65 acting as a “bead” or positional            feature that could be used for adjustability. For example a            retainer strap 63 of silicone could be bonded on both sides            to create a narrow passageway 66 where the clip 65 could be            placed in the compressed position, and then expand open            after passing through the strap 63 to maintain its position.            Several straps 63 could be bonded in a row to create several            positional locations. FIGS. 47B and 47D shows the clip 65 in            is open, relaxed state, where 47C shows the clip 65 in a            compressed state where it can pass through the retainer            strap 63.        -   FIG. 48 shows an adjustment element 60 with another option            for adjustability where one or more compressible clips 67            are added to one of the connecting element members which has            several positional locations. A clip retainer fixed to one            side of the connecting element 25 could be compressed to            open the clip 67 and then advance it over the positional            features such as a bead 62, and then allow it to spring            closed to fix the location of the device 10. FIGS. 49A and            50A show the clips 67 in their relaxed, closed positions            where 49B and 50B show the clips 67 in their compressed,            open positions sufficient to let the bead 62 pass. FIGS. 51A            and 51B show options for a keyway for translational            adjustability.        -   FIGS. 52A and 52B depict another option for adjustability            where a locking ring 69 is used to fix the location of the            connecting loops 70 into the pyloric element 26. The pyloric            element 26 could have several positional features 71            connected to it. The loop 70 could also have several            positional features 72 attached to it. When the positional            features of the pyloric element 72 and connecting loop 70            are aligned, a locking ring 69 could be placed inside to            hold the position of the elements together and to alter the            length of the whole device 10 to be longer or shorter. In            another embodiment shown in FIGS. 53 and 54, the ring 69            could be fixed to the pyloric element 26 and compressed to            capture the positional features 72 located along the            connecting element 25.    -   In another embodiment, an instrument could act as a screw driver        to rotate a member to thread the two elements 73 closer or        farther apart. See FIG. 55.    -   The instrument could also have a needle to inject fluid into an        inflation element 74. Such an element may be a self sealing        membrane to increase or decrease the length, diameter or        stiffness through positive displacement of an expandable body.        The self sealing membrane could be an injection port or it could        be a self sealing surface on the expandable body, or the entire        expandable body could be comprised of a self sealing surface. In        all descriptions below, the term inflation element 74 can also        refer to an injection port or to an area on the expandable body        with a self sealing membrane. The self sealing membrane could        also be a self sealing valve which can be accessed by a blunt        needle or tube to allow access to add or remove fluid. FIG. 56        shows an inflation element 74 fixed to the pyloric element 26 or        the connecting element 25. This valve or port could be connected        by a fluidic path to an expandable body such as a sealed        inflatable body inside of an expansion joint 75 such as a piston        and cylinder. The valve could be accessed by an endoscopic        instrument with a blunt end, while an injection port could be        accessed by an endoscopic instrument with a non-coring needle        where saline or other suitable fluid could be injected or        removed from the port which would allow the inflatable body to        expand or contract to control the length of expansion. Although        this figure shows one expansion joint 75, the device 10 could        contain one or more with a manifold set up to deliver fluid from        the port to all of the expansion joints. In an alternative        embodiment, the system could also have an expandable body such        as a syringe type joint which would not require a sealed        internal inflatable body.    -   In another embodiment, the cardiac and/or pyloric element(s) 12,        26 could be equipped with one or more inflatable bodies, to        increase or decrease the size of those element(s). For example,        in FIG. 57, an inflatable body 76 is depicted atop the cardiac        element 12, with an inflation element 74 such as a valve or an        injection port on the connecting element 25. Inflating fluid,        which could be saline, water, air, or other suitable substances,        may be inserted or removed through the inflation element 74 to        increase or decrease the size of the inflatable body 76. In such        manner, the amount of contact and/or pressure imparted by the        cardiac element 12 on the cardiac region 40 and/or the upper        region of the stomach may be adjusted, either while the device        10 is in the stomach, or prior to placement. This balloon could        cover the entire cardiac surface or could only cover portions of        the cardiac surface to direct the inflation for a specific        response. There may be one or more inflatable portions on the        cardiac element 12. FIG. 57 also depicts a similar inflatable        body 77 on the outside surface of the pyloric element 26. This        could be accessed in the same manner as the cardiac inflatable        body described above. Similarly, the inflatable body 77 could        cover the whole surface of the pyloric element or could be have        a portion or multiple portions for a desired effect. FIGS. 58A        and 58B, shows a linearly inflatable body 78 on the bottom or        distal surface of the pyloric element 26 to primarily allow for        elongation of the element. The device 10 could contain linear        and radial inflatable bodies.    -   A gastroscopic instrument could also deliver heat directly to an        expandable body such as a heat expanding mechanism (such as one        made of Nitinol) for expansion of a wax or wax-like expansion        member.        -   For example, a Nitinol clip could clip into a positional            location on a strut. The instrument could heat the clip to            release and then reposition it into a different location,            remove the heat and allow the clip to re-engage the            positional feature to lock it into place.    -   The instrument could also have an inflatable body or a balloon        to allow for physical contact with the device 10 to disengage a        feature for repositioning into another location.    -   Magnetic actuation. Another adjustment mechanism could use        magnets. See FIGS. 59, 60, and 61A and 61B.        -   For example, the positioning and/or connecting element 13,            25 could contain a thread with a magnetic nut 79 placed over            it. Another strong magnet, the controller magnet 80, could            be placed in close proximity to the implanted magnet to            cause it to rotate. The rotation of the controller magnet 80            could create a magnetic field which would cause the internal            magnet 79 to turn allowing it to advance and retreat along            the threaded member 81.        -   The controller magnet 80 could either be external to the            body or it could be placed on the end of a gastroscopic            instrument for close proximity.        -   The controller magnet could be a magnet or an electromagnet            to increase the intensity of the field and to improve            magnetic coupling to ensure actuation.        -   The controller magnet 80 could also be multiple magnets to            improve magnetic coupling.    -   Another means of manually adjusting the length of the device 10        would be to have modular pieces that could attach or adhere to        the cardiac or pyloric elements 12, 26. For example, an        additional frusto-cone 82 could be placed over the pyloric        element 26 to increase the length of the overall design. Several        could be stacked together to create a variety of lengths. See        FIGS. 62, 63 and 64. Stacking frusto-cones 82 could also be        distanced from one another with a balloon on either frusto-cone        to increase the distance between the two.    -   A variation of this embodiment would be to have an additional        member that could be collapsible or compressible and inserted        down the center of the pyloric element 26. Once it passes the        pyloric element distal surface 83, the modular element 82 would        expand and attach to the outer surface. Several modular elements        82 could be stacked together to create a variety of lengths. See        FIGS. 62 and 63.    -   An alternative embodiment could have an additional element that        could also pass down the center of the pyloric element 26 and        expand past the distal surface 83, but with a clip 84 that would        allow it to remain clipped to the inside surface. See FIG. 64.        The attachment mechanism could be positionally based so that the        element could be repositioned to several locations for a variety        of lengths.    -   There could be several other means for manually actuating the        design for repositioning.

As another variation of the above embodiments, the manual expansionmechanism could be adjusted remotely by an apparatus outside the body,and/or automated. The expansion could be achieved by a small motor thatcould be driven by an implanted power source or driven by a remote powersource such as induction. The automated expansion could also be achievedby a pump, a syringe type plunger, a piezoelectric crystal, a bellows, aNitinol motor, a pH responsive material that changes shape, thermalexpansion of a gas, fluid or solid (example wax) expansion, magnetforces or any other type automated expansion or compression mechanism.

The control for activating this mechanism could be a remote controlusing a radiofrequency signal which can pass through tissue. The remotecontrol could also be achieved by magnetic fields, time varying magneticfields, radio waves, temperature variation, external pressure, pressureduring swallowing, pH of any frequency or any other type of remotecontrol mechanism.

Actuation Mechanisms

Stepper Motor:

-   -   To adjust the length of the positioning and/or connecting        element 13, 25 to increase the direct force onto the upper        stomach or cardia 40, the adjusting element could be the        positioning and/or connecting element 13, 25 entirely or        partially comprised of a flexible, semi-flexible or rigid screw.        A stepper motor 85 could be placed onto the flexible thread and        could drive forward or back to allow the positioning and/or        connecting element 13, 25 to draw together or push apart the        elements. See FIGS. 65 and 55. These figures represent a        threaded element that can be drawn together or apart.    -   The adjusting element may require power to drive the motor 85.        The power could be supplied by an implanted power source such as        a battery or it could be powered externally by induction through        the coupling of an external antenna and an internal antenna.        -   An option would be to embed the internal antenna into any or            all of the elements. This would allow for fewer structures            in the design by encasing the antenna inside of one or more            of the existing elements. The antenna could be a simple ring            at the top or bottom or obliquely on either element or it            could be placed in the wall of the device 10. The internal            antenna could also be attached by a tether, free floating            inside the esophagus, stomach or intestine. These could be            made from materials to make them MM compatible and/or MM            safe. This feature could be applied towards any actuation            method where it is powered by induction.        -   For induction, an external hand held controller 86 may be            required to transmit power for coupling. See FIGS. 66            and 67. The controller 86 could be set up to auto detect the            internal antenna's presence and identify when coupling            between the two antennas was adequate to allow for            transmission and powering to take place, and to inform the            user of function. This external controller 86 could then be            used to display the distance that the stepper motor 85 had            been advanced or retracted to allow the physician to control            the adjustment. Similarly, the external controller 86 could            be used for communication and control signals as an            interface between the physician and the placed device 10.            This feature could be applied towards any actuation method            powered by induction.        -   An external antenna would be required for induction and            could be placed into an external handheld controller 86.            This could be placed directly against or close to the            patient's body at the height of the internal bariatric            device 10. The antenna could be housed with the other            controller electronics in a single unit. This feature could            be applied towards any actuation method powered by            induction.        -   Another alternative would be to have the external antenna in            the form of a belt 87 that would wrap around the patients            abdomen at the height of the device 10 to better align the            antennas for improved coupling. This feature could be            applied towards any actuation method powered by induction.            See FIG. 67.    -   The location of the actuation mechanism could also be inside any        of the elements, or above or below any of them, or another        location as would be best suited for the anatomy and function of        the device 10. This feature could be applied towards any        actuation method. Actuation could be accomplished by allowing        the screw to be pushed or pulled inside any of the elements to        embed the adjustment mechanism internally to one of the other        elements. Other actuations mechanisms such as those listed above        or others could also be used for this adjustment.    -   Induction could also be powered by an intragastric instrument.        The instrument could have a flexible shaft that could fit        through the mouth and down the esophagus or down the working        channel of a gastroscope. Once the instrument was placed within        or near the esophagus or stomach, it would allow the instrument        to be in close proximity with the actuation mechanism in the        device 10. The end of the instrument could have antenna(e) to        allow for inductive powering and/or communication with the        actuation mechanism for adjustment. This feature could be        applied towards any actuation method.

Piezoelectric Motor

-   -   The adjustment could also be achieved by a piezoelectric element        or motor 85. See FIGS. 65 and 55. These figures represent a        threaded element that can be drawn together or apart.    -   There are several types of piezomotors that could be used for        linear actuation. For example, a motor from NewScale        Technologies (www.newscaletech.com) called the Squiggle Motor        could be used which is very low profile and can be actuated when        powered. Other motors or actuation mechanisms could also be        used, and the Squiggle motor is just used as an example. In this        example, there is a rigid screw that passes through the center        of a threaded piezoelectric “tube” or element. When powered the        piezoelectric element flexes side to side along the central axis        to create an oscillating “hula hoop” action which causes it to        translate axially along the rigid screw. The Squiggle motor        could be attached to the positioning and/or connecting element        13, 25 to advance or retract the cardiac and/or the pyloric        element 12, 26. Alternatively, the Squiggle motor could be        placed in between any of the elements. Alternatively, more than        one Squiggle motor could be placed at these locations. One of        the advantages of a piezoelectric motor 85 is that it would        allow the device 10 to be MM compatible and safe. As mentioned        with the stepper motor 85 above, the piezoelectric motor 85        could be powered by an internal power source such as a battery        or it could be powered by remote induction. The remote induction        could be by a handheld external controller or it could be by a        gastroscopic instrument placed down the esophagus. This motor        could be encased in other materials to keep it dry and protected        from the stomach environment.    -   Another embodiment of a piezoelectric actuated motor 85 would be        to have a rotating piezoelectric member that could thread along        one or two threaded members similar to a worm gear.    -   Another embodiment of a piezoelectric actuated motor 85 would be        to have a piezoelectric crystal that elongates or flexes to        actuate another member.    -   All of the piezoelectric motors 85 may contain a sealed housing        such as an expandable metal or plastic bellows to prevent        moisture of fluid from contacting the piezoelectric elements.

Magnetic Actuation

-   -   As mentioned above in the manual adjustment section, another        adjustment mechanism could use magnets.    -   For example, at least a portion of the second element could be a        semi-flexible thread or rigid thread with a magnetic nut placed        over it. Another strong magnet, named a controller magnet 80,        could be placed in close proximity to the implanted magnet to        cause it to rotate. The rotation of the controller magnet 80        could create a magnetic field which would cause the internal        magnet to turn allowing it to advance and retract along the        threaded member.        -   The controller magnet 80 could either be external to the            body or it could be placed on the end of a gastroscopic            instrument for close proximity.        -   The controller magnet 80 could be a magnet or an            electromagnet to increase the intensity of the field and to            improve magnetic coupling to ensure actuation.        -   The controller magnet 80 could also be multiple magnets to            improve magnetic coupling.

Nitinol Actuation

-   -   The adjustment element could also be actuated by Nitinol or a        substance with similar properties. When a current is passed        through Nitinol, it heats and causes the Nitinol to change its        shape. Nitinol can expand into a variety of different shapes. A        linear actuator could be made from Nitinol to advance or retract        along an actuation member.        -   Heat could be generated from an implanted battery or it            could be delivered by induction.        -   The second element could have multiple positional features            such as holes, grooves, teeth or a wedging feature. A            Nitinol clip could have a feature to engage these positional            features. The Nitinol clip could be heated to change shape            to allow it to advance or retract into different positional            features to increase or decrease the length.        -   There are other Nitinol actuations that could be provided as            well.

Ultrasound Motor

-   -   Another adjustment mechanism could be by use of an ultrasound        motor or one powered by external ultrasound. This could use        external ultrasound equipment to send sonic waves into the body        to actuate the motor. This would also provide an Mill compatible        option without requiring an internal power source or induction.

Hydraulic Actuation

-   -   The adjustment element 60 could also be actuated through        hydraulic means for radial expansion or linear actuation as        previously described. The cardiac or pyloric element 12, 26        could be inflated with a fluid to increase the diameter or        length of the device 10 to increase pressures against the upper        stomach or cardia 40, and pyloric region 42. It could increase        in volume by accessing a self sealing membrane such as a self        sealing drug delivery port, self sealing membrane on the        expandable body, or a self sealing valve attached to the device        10. The inflation could be achieved by a piezoelectric pump, a        peristaltic pump, a positive displacement pump or a syringe        pump.        -   Piezoelectric pump: The pump could be comprised of a            piezoelectric element which can flex to propel fluid            directly or a member that could propel fluid. For example, a            piezoelectric disk could be captured in a housing with an            incoming channel and an outgoing channel. The disk could be            powered to cause it to flex into a dome shape to push fluid            into the outgoing channel. A valve would be required to            close the incoming channel to ensure directional flow to the            outgoing channel. Similarly, the piezoelectric Squiggle            motor as described above could be used to linearly actuate a            fluid up or down a tube to hydraulically actuate position.        -   Stepper motor pump: Actuation could be achieved by a stepper            motor where the motor linearly actuates to compress a            reservoir or syringe to move fluid within a tube or            constrained volume.        -   Wax expansion pump: Fluid could also be propelled by a wax            expansion mechanism. When wax is heated to melting it            expands by approximately 30%. A solid plug of wax could be            heated to expand and drive fluid through a valve to            hydraulically actuate lengthening. The lengthening structure            could be made to move only in one direction, so that when            the wax cools it will not contract. The wax expansion could            also be used to actuate other adjustment mechanisms.        -   Peristaltic pump: The members could also be driven by a            peristaltic pump. In this mechanism, the external diameter            of a cylindrical actuator could be used to compress a length            of tubing to create an occlusion. The cylindrical actuator            could be rotated along the tube to drive fluid forward or            backwards inside the tube. The peristaltic pump could also            be actuated by a stepper motor or by a piezoelectric element            or other.        -   Gas expansion/propellant pump: The length could also be            actuated by a gas expansion pump where a gas like Freon or            others could be used to expand when exposed to a higher            temperature. Similar principles to the devices like the            Codman pump could be used. This change in volume could drive            the pump forward. Similarly, there could be compressed gas            constrained in a pressure vessel with a valve. The valve            could be remotely activated to allow gas to propel a            syringe, fluid or to compress a constrained volume.        -   Positive displacement pump: There are implant grade positive            displacement pumps that are available on the market for drug            delivery that could be used to displace a specific amount of            fluid for hydraulic inflation of the adjustment element 60.        -   Syringe pump: A syringe pump could be made by advancing            fluid through a syringe. The syringe could be actuated by a            stepper motor, a piezoelectric actuator, a magnet or by a            Nitinol actuator as described above.        -   Hydrogel: the adjustment element could also be inflated by            use of a hydrogel to absorb fluids and could be actuated by            changes in temperature, pH or tonicity to change shape or            volume        -   Hypertonic fluid: the adjustment element 60 could also be            inflated by using a hypertonic fluid in the inflation area            and allowing it to absorb fluid across a semi permeable            membrane.

Mechanical means for diametrical changes. Similar to the inflation,elongation, and shortening embodiments described above, the device 10could change diameter by various actuation mechanisms. All of theabove-described mechanisms could also be adapted for use for a diametricchange instead of a linear change.

As a variation of the embodiments discussed above, the device 10 couldhave a sensor 88 that could sense a parameter such as pressure, motion,peristalsis, tension, pH, temperature, or other appropriate parameters,or various parameter combinations. The sensor 88 could output a signalto be used by an actuation element to actuate an adjustment element, toa memory element such as a microchip, or be read by a remote reader orremote controller.

Sensors 88 could be used to gather important patient data to understandperformance, patient status or whether an adjustment needs to beperformed. For ease of use and compatibility with the body, wirelesssensors would be preferred. The sensors 88 could be direct tissuecontact, intermittent patient contact or could monitor the intraluminalpressure inside GI tract. The data could be used for no other reasonthan to just monitor patient status. FIGS. 68 and 69 depict sensors 88,which could be embedded in any of the elements or it could be tetheredto any of the elements to allow it to be suspended inside the GI tract.Based on the sensed parameter, the device 10 could be adjusted. Theadjustment could have an open or closed loop system increasing ordecreasing the applied force, pressure or sensed parameter. The sensedparameter could detect whether the device 10 was not at an idealcondition, and could then send a signal to a control mechanism forautomatically adjusting the system. This mechanism could be underphysician control (open system) or without physician control (closedsystem). It could also control the shape of the cardiac, pyloric,connecting, and/or positioning elements 12, 26, 25, 13 to varystiffness, size, length, form or shape. In general, the sensor 88 couldsense a parameter and then adjust the device 10 as needed to bring thesensed parameter into the ideal range. There could be an algorithm thatcontrols the ideal parameter or it could be based on a parameter range.The device 10 would be adjustable to meet the needs of the patient.

In an open loop system, the physician would have control of when thedevice 10 would adjust. The device 10 could be passive and onlyinductively powered when in close proximity to an external controllerunder the supervision of a physician. For example, in the clinic thephysician could have a remote controller with the ability of poweringthe device 10 inductively, and then begin to monitor the sensorsfeedback signals to see physical parameters of the patient at baselinesuch as pressure of the device 10 against the cardia. The sensormonitoring could also be performed while the patient is eating ordrinking, or not eating or drinking. As the patient consumes, theesophageal and stomach peristaltic waves will increase in intensity asthey propel the food or drink from the mouth to the stomach. A sensor 88could detect when these waves increase in amplitude, frequency, andpressure. The parameter could read on the external controller by thephysician, and then the physician could send a signal to the automatedexpansion mechanism in the device 10 to adjust the device. The physiciancould then query the sensor 88 again to determine whether the device 10was in the ideal settings and whether the pressure against the cardia orsensed parameter was optimized. The physician could iteratively controlthe amount of adjustment and monitor the parameters until the idealcondition was met.

Alternatively, the physician could read the parameter signals whileunder his supervision, but have the sensors 88 send a signal directly tothe automated expansion mechanism to adjust until the device 10 waswithin the ideal parameters. The data collected could be analyzed by thecontroller for averages, minimums, maximums and standard deviations overtime and use an algorithm to determine the ideal settings. Thecontroller could then monitor and adjust on its own until the idealconditions were met, but while the physician was present to verify allconditions and verify patient acceptance.

In a closed loop system, the device 10 would be active with its ownintegrated power source. The device 10 could wake up at routineintervals to monitor or could monitor all the time. The data collectedcould be analyzed for averages, minimums, maximums and standarddeviations over time and use an algorithm to determine the idealsettings. As the patient begins to consume food or drink, the devicesensors 88 would detect the sensed parameter and signal the automatedexpansion/contraction mechanism to adjust the device 10 as needed. Inthis embodiment, the device 10 could be fully automated and would notrequire intervention from an outside individual.

In either the open or closed loop system, there could be multiplesensors 88 on the device 10 to determine the pressure or force areas, orother sensed parameters on the device 10 and where it needs to be variedto meet the ideal conditions for the stomach. In the case where thepositioning and/or connecting element 13, 25 has multiple components,this could be used to align the device 10 in the stomach to provide acustom fit for each person. There could also be a mechanism to adjustthe alignment of the cardiac and/or pyloric elements 12, 26 relative tothe connecting and/or positioning element 25, 13. The sensor(s) 88 couldhave a built in power source or it could have a remote power source suchas induction so that it would only wake up and activate when an externalcontroller was brought near.

The device 10 could have integrated memory to allow storage of patientand device 10 data. This could include but is not limited to the serialnumber, the patient's information such as name, patient number, height,weight; the physician's name, the adjustment history including the dateand time, the amount adjustment and the sensed parameters. For theactive device, there could be 24 hour data recording of key parametersor there could be data collected at key intervals throughout the day todetect when the patient is eating and whether they are being compliantwith their eating. It could record weight tracking, BMI or other data asneeded which could be queried by an external controller. This data couldalso be downloaded into a physician's patient tracking database for easeof patient tracking. Similarly, this data could be downloaded andtracked on an internet tracking website, where the patient could log onand see their history and progress. The patient could add information tothe website such as weight or an eating log, adverse events or otherconditions that the physician or patient would like to track.

In the open system, the physician could choose to collect and recorddata as needed at the time of the adjustment such as weight, date, time,and adjustment amount or other.

For an open loop system, the device 10 could be adapted to allow forremote adjustments over the phone. This would be especially advantageousfor patients living in rural areas where they are far from theirphysician's office. It could also be for convenience of having anadjustment without having to travel to the physician's office. Thiswould allow a physician to discuss the patient's progress with thepatient directly and then query the device sensor 88 to see how thedevice performance is. Based on the feedback of the device 10, thephysician could then adjust the patient.

In yet another embodiment, the device 10 could have an emitter elementfor dispensing a drug, hormone or bioactive agent to further inducesatiety, weight management or other disease management such as diabetes.The drug could be a weight management drug currently on the market orone to be developed. Similarly, it could be a satiety hormone or otherbioactive agent. In the published literature, there is a growing mass ofinformation on satiety hormones. The bioactive agent could be applied bythe emitter element through a drug eluting coating, a reservoir with apump, or a permeable membrane placed on the device 10 where the drugscould pass from the device 10 into the gut. The emitter element couldrelease such substances in response to a signal from a sensor 88, atimed basis, or other release criteria. The device 10 could have a tubethat trails into the intestines to allow the drug to be delivereddownstream where the pH is higher and would not destroy the bioactiveagent.

The device 10 could have a surface finish or macrotexture for grippingthe stomach. If the device 10 could grip the inner mucosa of thestomach, it could elongate or expand to further stretch the stomach inkey areas to induce further satiety as needed. For example, the cardiacelement 12 could be a conical spiral with a surface texture that lightlygrips the mucosa and or stomach musculature. If the spiral were made ofNitinol or other temperature-sensitive substance, the device 10 couldexpand the spiral by a variation of temperature. By applying atemperature variation, such as by drinking a hot liquid or otherwise,the device 10 could expand and cause a satiety response. The surfacecould be multiple protuberances, barbs, a rough bead blast, or otherfinishes suitable for gripping the stomach wall.

The device 10 could have a thin flexible tube 89 attached to the pyloricelement 26 that could trail into the duodenum 19 to act as a barrier tofood absorption. See FIG. 70. This tube 89 would be of similar diameterto the duodenum 19 and all food passing through the pyloric element 26would pass directly into this sleeve. Similar to the rerouting performedin a gastric bypass or Roux en Y bypass, the sleeve 89 would beapproximately 100 cm long, but could be longer or shorter depending onthe amount of malabsorption required. This tube 89 may be made of anacid resistant material such as Teflon, PTFE, ePTFE, FEP, silicone,elastomers or other acid resistant materials.

As a variation of the device 10, it could incorporate electricalstimulation to the stomach musculature, stomach nerves or the vagus tofurther improve satiety stimulation and weight loss. Energy used forthis stimulation could be RF, ultrasound, microwave cryogenic, laser,light, electrical, mechanical or thermal. The device 10 could have leadsincorporated that could embed into the stomach wall or be surgicallyplaced around a nerve, or the stimulation could be applied directlythrough surface contact of the device 10 to the stomach mucosa.

In yet another embodiment, the bariatric device 10 may have anadjustment element 60 that is equipped with a temporaryexpansion/contraction element 90 that may allow for temporary adjustmentbased on activation of a material property, sensor 88 or mechanism ofthe device 10. This could be applied to any of the above-discussedembodiments. See FIGS. 71A, 71B, 72A, 72B, 73A, and 73B. It may bedesirable for the temporary expansion/contraction element 90 to adjustonly upon eating, and then retract after eating. It may be desirable forthe device 10 to adjust with the pH cycle of the patient where pH willbe higher prior to eating and then lower after eating. This would allowfor intermittent stimulation of the stretch receptors to avoid receptorfatigue over time. For example, the material could be heat sensitiveusing materials such as Nitinol, which could expand after consuming ahot liquid. Similarly, the device 10 could have a sensor 88 or materialthat is pH or glucose sensitive or detect the presence of food, whichcould activate the temporary expansion/contraction element 90 to expandwhen a certain threshold for pH has been reached or glucose or fat ispresent after eating. Similarly, this temporary expansion/contractionelement 90 could be activated by a magnetic field such as swallowing amagnetic pill that could temporarily expand the device 10. In thisexample, the magnetic pill would be small enough and shapedappropriately for passage through the gastrointestinal tract, andbiocompatible. The patient could consume the electromagnetic pill when asatiety signal was desired. It may also be desirable for the device 10to adjust based on time or sleep cycle such that the device 10 adjustsat specific times of the day or when the patient lays horizontal. Otherparameters or mechanisms to trigger the temporary expansion could beused.

Placement

As mentioned above, a tube, catheter, or sheath may be required toprotect the anatomy during placement of the device 10 down the esophagusand into the stomach. It could be a simple flexible tube such assilicone or urethane tube to aid in straightening and compressing thedevice 10 while it is being introduced. Insertion of the device 10 intothe tube would require compression of the device 10 into a narrow,insertable shape. A standard gastroscopic tool could be used to push orpull the device 10 down the tube. Similarly, a custom gastroscopic toolor sheath could be used to introduce the device 10 into the stomachthrough the esophagus or other narrow opening.

A delivery sheath 91 may be used to insert the device 10 though theesophagus 32 or other narrow opening into the stomach for placement. Inone such embodiment, a lightweight fabric, sheeting or material 92 maybe used for the sheath 91, made of a suitable material that is thin,flexible, soft, smooth, compliant, adequately lubricious to slide downthe esophagus 32 and adequately strong to hold the device 10 in acompressed state 93 such as fabrics made from polymers such as nylon,teflons, eptfe, polyester, or polymer coated fabrics such as ptfe coatedcotton or other fabrics or other sheeting materials. Although a fabriccould be used for the material 92, other substances may be used, such assilicone, polyurethane, thin walled plastic or other suitablesubstances. First, the bariatric device 10 may be compressed into anarrow shape to fit inside the sheath 91, and held in a compressed stateby a tube, fixtures, or the like. Then the material 92 may be drapedaround the compressed device 10 lengthwise, and secured in a closedposition with a deployment member 94. The material 92 could also beclosed with a deployment member 94 and the collapsed device 93 theninserted inside the closed sheath 91. The deployment member 94 could bea small gauge wire or lace placed in a single straight stitch along thelength of the material 92 around the compressed device 93, as shown inFIGS. 74 and 75. The deployment member 94 may be of any of a variety ofsuitable materials. In a preferred embodiment, the deployment member 94is a single thin wire, preferably capable of holding its original shapeeven after being bent. Such wire could be made of Nitinol, spring steel,small diameter braided cable or spiral wound guide wire, or othersuitable material. Although a deformable wire could be used, it may bemore difficult to remove for placement if the bends become too extremeduring handling. The deployment member 94 may also be thread material,such silk, rayon, nylon, polyester, eptfe thread, ptfe coated thread andthe like. The deployment member 94 may be terminated by stitching thedeployment member 94 around the distal end (the end inserted into thebody first) of the material 92 to close the distal end of the sheath 91,and turned back around and inserted inside the material 92 towards theproximal end.

Alternatively, the distal end of the deployment member 94 may be securedin a pocket attached to the interior or exterior of the material 92 ator near the distal end of the sheath. For the deployment member 94 suchpocket may be in the form of a plastic cap, silicone cap or othersuitable material that will protect the wire end from poking or snaggingtissue during placement. In such an embodiment, the distal end of thematerial 92 may be folded over towards the proximal end like an envelopeso that the deployment member 94 may secure the distal end of the sheathmaterial 92 without having to stitch around the end. The pocket may thenbe attached to the material 92 at or near the fold.

The deployment member's proximal end 96 may extend far enough so that itmay be accessed outside the patient after the device 10 is placed intothe deployment position in the stomach. Preferably, a thin tube 95 madeof silicone or plastic is secured to the proximal end of the material92, and the deployment member 94 is routed inside the tube 95. Such atube 95 may be independently secured to the material 92 so that thedistal end of the tube 95 is just inside the proximal end of thematerial 92. Then the compressed device 10 may be placed within thematerial 92 and secured with the deployment member 94. The result is apackage with a compressed device 93 inside the closed material 92 and atube 95 also secured inside the proximal end of the material 92, withthe deployment member 94 running through the tube 95. For adequatestiffness for placement, an additional guide wire may be needed to beplaced down the center the sheath assembly.

For placement, such a sheath package is placed into the esophagus 32 orother narrow opening or surgical incision, and routed into the stomach.Once in deployment position, the deployment member 94 is pulled throughthe tubing 95, which releases the closure of the sheath. The device 10will then expand or regain its operational shape. Then the tube 95,along with the material 92, may be removed from the patient leaving onlythe device 10 in place.

The delivery sheath 91 may be used for any delivery of any medicaldevice through a narrow opening. If the medical device is naturallynarrow, or can be compressed, deflated, or other means of holding it ina narrow shape, it may be placed in a delivery sheath 91 as discussedabove. After the deployment member 94 is pulled through the tubing 95,the medical device may expand or rebound into its operational shape,whether by its construction of shape-retaining materials, or bymechanical, hydraulic, pneumatic, or other means.

Measurement Tool

To select the appropriate size device or device adjustment for thepatient, a measurement tool may be used. This tool would allowmeasurement of the lesser and greater curves, 16, 17 of the stomach, thedistance between the pyloric and cardiac elements, or other features ofthe stomach.

In one embodiment, the measurement tool has an inflatable body 97 thatis in the same general shape as the pyloric element 26. This balloon maybe affixed to a central tube 98 to allow for a pathway where air can bepassed to inflate and deflate the balloon 97. The central tube 98 mayalso provide a handle for placing the balloon 97 and maneuvering theballoon into position in the pyloric region 42. The central tube 98measurement member may be used alone or in conjunction with additionalmeasurement members. See FIGS. 76 and 77. For placement, the inflatablebody 97 would be deflated to collapse it to a narrow, low profile, andpreferably inserted into the stomach through the esophagus 32. See FIG.78.

A measurement member could be affixed to the inflatable body withadequate length to start a measurement at the base of the pyloricinflatable body 97 and measure along the lesser curve 16 or greatercurve 17 to the gastroesophogeal (GE) junction. This measurement membercould be long enough to pass up the esophagus for manipulation outsidethe body or could be long enough to pass the GE junction. Thismeasurement member may be equipped with measurement markings 99, whichcould be a thin measurement tape 100, a tube with length markings 101,the central tube coupled with the inflatable body, or a clear tube witha plunger to allow for visualization of the plunger with the measurementon the plunger. For the clear tube/plunger embodiment, the measurementmarkings could be on the tube for visualization by the gastroscope, orthe measurement markings may be on the plunger such that when the bottomor other part of the plunger is aligned with the stomach feature, themeasurement is read outside the body by viewing the markings on theplunger relative to a point on the tubing. Once the inflatable body 97is in position in the pyloric region 42, the inflatable body 97 could beinflated to match the shape and profile of the pyloric element 26.Alternatively, the inflatable body 97 may be inflated in the stomach andthen pushed into the pyloric region 42.

Once the inflatable body 97 is seated in the proper position, variousfeatures of the stomach may be measured. For the lesser curvemeasurement, the inflatable body 97 may be positioned so that themeasurement member is located along the lesser curve 16. Undergastroscope visualization, the measurement member could then be pulledup to position in the GE junction by the member itself or by aninstrument, and the measurement reading noted. For the greater curvemeasurement, the inflatable body may be positioned so that themeasurement member is located along the greater curve 17. Undergastroscope visualization, the measurement member could then be pushedinto position along the greater curve 17 and up through the GE junctionby the member itself or by an instrument, and the measurement readingnoted. The measurement members could be made of silicone, an elastomeror other material that is compliant and smooth. The measurement membershould be of adequate strength to maintain a good measurement, but besmooth and complaint for placement down the esophagus and for conformingto the stomach's anatomy.

In another embodiment, the instrument may contain two measurementmembers on opposing sides of the inflatable body to measure the greaterand lesser curves at the same time as shown in FIG. 77. In anotherembodiment, the central tube 98 could also be used as a measurementmember and pushed to flex and contour along the greater or lesser curve16 for a measurement. See FIG. 76. Preferably, the inflatable body 97matches shape of the pyloric element 26 of the device 10, but it couldalso take another shape such as a sphere to approximate the size of thepyloric element 26. The inflatable body may also be shaped for othermeasurement uses, and adapted to fit whatever area of the stomach may berequired. Alternatively, the inflatable body could be replaced with anon-inflatable body if needed. In the embodiment where the central tube98 is used for measurement, the central tube 98 could be offset from thecenter of the inflatable body 97 to allow it to better contour to thegreater or lesser curves 17, 16.

In another embodiment, the measurement tool may contain a fixed pyloricmember and a moveable cardiac member that can translate along a centraltube 98 to approximate the distance between the two members in therecipient's stomach. The central tube 98 may contain measurementmarkings 99 that can be visualized once the cardiac member has beenpositioned. The cardiac member may include a pressure sensor to guidewhen adequate pressure has been incurred to represent proper seating ofthe cardiac device 10 in the stomach.

In another embodiment, the measurement tool may comprise an inflatableballoon at the pylorus and an inflatable balloon near the cardia. As thecardiac balloon is inflated, it may approximate the location of thecardia. The cardia balloon may contain a pressure sensor internally orexternally to guide when an appropriate contact pressure to the cardiahas been achieved to approximate the size.

Removal

For removal, a flexible tube such as a standard overtube could be usedwith a standard or custom endoscopic tool. The tube may be placed downthe esophagus and the tool then placed down the lumen of the overtube. Astandard tool such as a grasper or snare could grasp the device 10 andpull it up the tube. The device 10 would be straightened by the overtubefor removal from the stomach and esophagus.

In another embodiment, the elements may incorporate a collapsingmechanism designed to collapse the element into a compact shape forremoval. For example, FIGS. 79 and 80 depict a pyloric element 26 with aconstriction member 102 comprising a wire or thread sewn spirallyaround, through, or inside the length of the element. The constrictionmember 102 could also be sewn through eyelets or features attached tothe inside of the pyloric or cardiac element 26, 12. The ends of theconstriction member 102 may be connected. When the constriction member102 is pulled, it tightens the circumference of the pyloric element 26like a drawstring, which collapses the element down to a narrow profilethat can be safely removed through the esophagus or other narrowopening, or ease its placement into a tube for removal. Similarcollapsing mechanisms can be installed in the cardiac, connecting,and/or positioning elements 12, 25, 13. The constriction member 102could be made from Nitinol, stainless steel wire, ptfe thread, eptfethread or ptfe coated threads or other suitable materials. Theconstriction member 102 could be integrated into the elements in avariety of patterns such as a continuous spiral, two spirals ofreversing orientation, or other.

The constriction member 102 may also be threaded through a retainingelement 103 to aid in maintaining the collapsed position such as adrawstring cord stop or the like. See FIGS. 81A, 81B and 82. This figureshows a stop element that is affixed to the pyloric element 26 and theconstriction member is threaded through. For example, this mechanicalstop 103 could be a thick sheet of silicone with a slit or small holepunched through the center section, and the retrieval drawstring ispulled through the opening. When the constriction member 102 is pulled,it is drawn through this stop element 103 and the mechanical stopapplies resistance to the retrieval drawstring to hold the device 10 inthe collapsed state. To further improve the holding capacity of themechanical stop 103, a feature could be added to the retrievaldrawstring 102 such as a knot tied or an arrowhead or bead attached tothe drawstring that allows the feature to be pulled through the slit ofthe mechanical stop 103, but creates a mechanical interference toprevent the drawstring from pulling back through the stop. Themechanical stop could also be a cord stop 103 as shown in 81A.

The foregoing description of the preferred embodiments of the inventionhas been presented for the purposes of illustration and description. Itis not intended to be exhaustive or to limit the invention to theprecise form disclosed. Many modifications and variations are possiblein light of the above teaching. It is intended that the scope of theinvention not be limited by this detailed description, but by the claimsand the equivalents to the claims appended hereto.

INDUSTRIAL APPLICABILITY

This invention may be industrially applied to the development,manufacture, and use of bariatric devices for weight loss purposes.

What is claimed is:
 1. A bariatric device for placement into a stomachto achieve weight loss, comprising a) a cardiac element adapted toengage the upper stomach; and b) at least one of the following chosenfrom the group consisting of: i) a pyloric element adapted to engage thepyloric region of the stomach, and a connecting element coupling thecardiac element and the pyloric element, shaped such that the cardiacelement maintains at least intermittent contact with the upper stomachand the pyloric element maintains at least intermittent contact with thepyloric region of the stomach, ii) a positioning element shaped suchthat the cardiac element maintains at least intermittent contact withthe upper stomach, and iii) a positioning element shaped such that thecardiac element maintains at least intermittent contact with the upperstomach, and a pyloric feature to preclude the positioning element frommoving substantially past the pyloric valve.
 2. The bariatric device ofclaim 1, wherein an outwardly biasing force is applied by at least oneof the group consisting of: the connecting element, which applies anoutwardly biasing force to the cardiac and pyloric elements, and thepositioning element, which applies an outwardly biasing force to thecardiac element.
 3. The bariatric device of claim 2, further comprisinga sensor element that generates a signal based on sensed conditionswithin the stomach.
 4. The bariatric device of claim 3, furthercomprising: an adjustment element to adjust the outwardly biasing forcewhile the bariatric device is located within in the stomach, and anactuation element which actuates the adjustment element based uponsignals received from the sensor element.
 5. The bariatric device ofclaim 4, wherein the sensed condition for adjustment of the outwardlybiasing force is at least one chosen from the group of: pressure, forcemotion, peristalsis, tension, pH, temperature, and chemical detection.6. The bariatric device of claim 1, further comprising an electricalstimulation element.
 7. The bariatric device of claim 6, wherein theenergy used for the electrical stimulation is at least one chosen fromthe group consisting of: radio frequency, ultrasound, microwave,cryogenic, laser, light, electrical, mechanical, and thermal.
 8. Thebariatric device of claim 3, further comprising an adjustment elementthat adjusts the outwardly biasing force in response to signals receivedby a controller located outside of the body, and wherein the signalsfrom the sensor element can be obtained outside of the body.
 9. Thebariatric device of claim 8, wherein the adjustment of the outwardlybiasing force is determined from signals obtained from the sensorelement.
 10. The bariatric device of claim 3, further comprising amemory element to store the signal data.
 11. The bariatric device ofclaim 8, further comprising a sensed parameter data reader capable ofreading the sensed parameter data from outside the body.
 12. Thebariatric device of claim 4, further comprising a sensor signalinterpretation and control element, which in response to preprogrammedset of signals, adjusts the outwardly biasing force.
 13. The bariatricdevice of claim 3, further comprising: an emitter element, and a sensorsignal interpretation element, which in response to preprogrammedsignals, triggers the emitter element to emit a substance into thegastrointestinal tract.
 14. A stomach measuring tool for introductionthrough the esophagus to the stomach, comprising: a) an inflatable body,which when inflated is adapted to engage the pyloric region of thestomach, and which when deflated has a narrow profile, b) tubing coupledwith the inflatable body, c) a measurement member having measurementmarkings, said measurement member coupled with the inflatable body orthe tubing.
 15. The measuring tool of claim 14, further comprising:measurement markings on the tubing.
 16. A stomach measuring tool forintroduction through the esophagus to the stomach, comprising: a) aninflatable body, which when inflated is adapted to engage the pyloricregion of the stomach, and which when deflated has a narrow profile, b)tubing coupled with the inflatable body, and c) measurement marking onthe tubing or a plunger located inside the tubing.